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OREGON PATIENT SAFETY COMMISSION

 

DIVISION 20
OREGON PATIENT SAFETY REPORTING PROGRAM FOR

LONG TERM CARE FACILITIES

325-020-0001
Definitions
As used in OAR 325-020-0001 to 325-020-0055:
(1) "Commission" means the
Oregon Patient Safety Commission.
(2) "Event Report" means
the form designated by the Commission to be used by Long Term Care Facility Participants
for the reporting of Reportable Long Term Care Facility Serious Adverse Events.
(3) "Long Term Care Facility
Participant" means a long term care facility as defined in ORS 442.015(18) and licensed
under OAR 411, division 085, that has volunteered to participate in the Oregon Patient
Safety Reporting Program.
(4) "Oregon Patient Safety
Reporting Program" means the Patient Safety Reporting Program as defined in ORS
442.837, and operated by the Commission.
(5) "Participant" means an
entity that reports Patient Safety Data to a Patient Safety Reporting Program, and
any agent, employee, consultant, representative, volunteer or medical staff member
of the entity.
(6) "Patient Safety Activities"
include but are not limited to:
(a) The collection and analysis
of Patient Safety Data by a Participant;
(b) The collection and analysis
of Patient Safety Data by the Oregon Patient Safety Commission established in ORS
442.837 and 442.820;
(c) The utilization of Patient
Safety Data by Participants;
(d) The utilization of Patient
Safety Data by the Oregon Patient Safety Commission to improve the quality of care
with respect to patient safety and to provide assistance to health care providers
to minimize patient risk; and
(e) Oral and written communication
regarding Patient Safety Data among two or more Participants with the intent of
making a disclosure to or preparing a report to be submitted to a Patient Safety
Reporting Program.
(7) "Patient Safety Data"
means oral communication or written reports, data, records, memoranda, analyses,
deliberative work, statements, root cause analyses or action plans that are collected
or developed to improve patient safety or health care quality that:
(a) Are prepared by a Participant
for the purpose of reporting Patient Safety Data voluntarily to a Patient Safety
Reporting Program, or that are communicated among two or more Participants with
the intent of making a disclosure to or preparing a report to be submitted to a
Patient Safety Reporting Program; or
(b) Are created by or at
the direction of the Patient Safety Reporting Program, including communication,
reports, notes or records created in the course of an investigation undertaken at
the direction of the Oregon Patient Safety Commission.
(8) "Reportable Serious Adverse
Event" for the purposes of OAR 325-020-0001 to 325-020-0055 means any unanticipated,
usually preventable consequence of patient care that results in patient death or
serious physical injury, including the events described in Appendix A, incorporated
by reference.
[ED. NOTE: Appendices referenced are
available from the agency.]
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 1-2007, f. &
cert. ef. 3-9-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-020-0005
Enrollment in the Oregon Patient
Safety Reporting Program
(1) Participation in the Oregon Patient
Safety Reporting Program is voluntary. Long Term Care Facility Participants are
entitled to the benefits and subject to the obligations set forth in these administrative
rules.
(2) Interested long term
care facilities may apply for participation in the Oregon Patient Safety Reporting
Program by completing the Commission's participation agreement. The participation
agreement must include the name of a designated contact person.
(3) In agreeing to participate
a long term care facility must affirm that it is willing to fully share requested
Patient Safety Data with the Commission. This statement must be co-signed by the
nursing home administrator, Director of Nursing Services, and the principal owner
or Chairperson of the Board of Directors, or their equivalents.
(4) Upon enrolling in the
Oregon Patient Safety Reporting Program, a Long Term Care Facility Participant must
have adopted policies and procedures describing patient safety activities, including
how it triages adverse events; how it investigates adverse events; and how it provides
notice of adverse events to a patient and/or family member. The Long Term Care Facility
Participant must provide copies to the Commission upon request.
(5) Within 30 calendar days
of receipt and acceptance of the participation agreement the Commission will issue
a certificate establishing a Long Term Care Facility Participant's enrollment in
the Oregon Patient Safety Reporting Program. The Long Term Care Facility Participant
should post the certificate in public view.
(6) The Commission will maintain
and update a website that lists all Long Term Care Facility Participants.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 1-2007, f. &
cert. ef. 3-9-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-020-0010
Annual Long Term Care Facility Participant
Fee
(1) All long term care facilities licensed
under OAR 411, division 085 must pay an annual fee. Per ORS 442.850 these fees will
be assessed independent of participation status in the Oregon Patient Safety Reporting
Program. Long term care facilities with six beds or less will pay an annual fee
of $150 per long term care facility. Long term care facilities with greater than
six beds will pay an annual fee of $800 per long term care facility.
(2) Initial fees will be
due by December 31 of the year a long term care facility becomes licensed by the
state of Oregon. Annual fees will be due by December 31 each year. Any uncollected
fees are turned over to the Department of Revenue for collection on or after April
1 following the date of invoice.
(3) No participation fees
will be refunded due to withdrawal or termination from the Oregon Patient Safety
Reporting Program.
(4) Fees shall be annually
adjusted by the Commission Board, at a rate equal to the annual average Consumer
Price Index for All Urban Consumers of the Portland, Oregon, Metropolitan Statistical
Area, as compiled by the United States Department of Labor, Bureau of Labor Statistics,
for every fiscal year beginning on or after July 1, 2008.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 1-2007, f. &
cert. ef. 3-9-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-020-0015
Termination of Participation
(1) The Commission's reporting program
relies on voluntary reporting. However, the Commission is responsible for ensuring
that those who choose to participate also comply with the standards established
by the Commission.
(2) Participation requirements
include the reporting of all Reportable Serious Adverse Events; fully completing
Event Reports; creating and implementing acceptable action plans; and providing
written disclosure to patients or families following a Reportable Serious Adverse
Event.
(3) If the Commission believes
a Long Term Care Facility Participant is not meeting its participation requirements,
the Commission must provide the Long Term Care Facility Participant with a written
notice explaining why. The Long Term Care Facility Participant will have 30 calendar
days to respond and come into compliance.
(4) The Commission may deny,
suspend or revoke a Long Term Care Facility Participant's status when the Commission
finds that there has been a substantial failure to comply with the provisions of
participation.
(5) Upon written notification
by the Commission of revocation, suspension, or denial of a Long Term Care Facility
Participant enrollment in the Oregon Patient Safety Reporting Program, a Long Term
Care Facility Participant may request a hearing. Hearings will be held in accordance
with ORS 183.310 to 183.470.
Stat. Auth.: ORS 442.820
Stats. Implemented: 442.819-442.851
Hist.: PSC 1-2007, f. &
cert. ef. 3-9-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-020-0020
Re-Issue of Suspended or Revoked
Participation Certificate
The Commission may re-issue a participation
certificate that has been suspended or revoked if the Commission determines that
the long term care facility applying for re-enrollment meets the provisions of participation.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 1-2007, f. &
cert. ef. 3-9-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-020-0025
Reporting Serious Adverse Events
(1) The Commission will provide an Event
Report form to be used by Long Term Care Facility Participants for reporting Reportable
Serious Adverse Events. The Event Report will include: a summary description of
the event; an overview of the Long Term Care Facility Participant's complete, thorough
and credible investigation of that event; and information about improvement strategies
designed to minimize risk of future events. The meaning of terms "complete," "thorough,"
and "credible" are explained in OAR 325-020-0030.
(2) Long Term Care Facility
Participants must use the Event Report form when reporting Serious Adverse Events
to the Commission.
(3) Long Term Care Facility
Participants must submit a completed Event Report to the Commission within 45 calendar
days of discovery of a Reportable Serious Adverse Event.
(4) Subject to a separate
written agreement between the Commission and Long Term Care Facility Participant,
Participant will share additional resident assessment data with the Commission,
to the extent permitted by state and federal law.
(5) If a Long Term Care Facility
Participant believes the Commission should immediately issue an alert to all Oregon
Long Term Care Facilities or other types of Participants based on a specific Reportable
Serious Adverse Event, the Long Term Care Facility Participant should provide an
initial report to the Commission within 3 business days of discovery of the event,
or sooner. The Long Term Care Facility Participant and Commission will work together
to identify information to include in the alert.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 1-2007, f. &
cert. ef. 3-9-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-020-0026
Long Term Care Reporting of Less
Serious Adverse Events or Close Calls
(1) In addition to Reportable Serious
Adverse Events, Long Term Care Facility Participants are also encouraged to report
less serious adverse events or close calls. Long Term Care Facility Participants
should do so when they believe other organizations will benefit from the information.
(2) To report such events,
Long Term Care Facility Participants should use the appropriate sections of the
Event Report form.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 1-2007, f. &
cert. ef. 3-9-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-020-0030
Commission Review of Reports
(1) When the Commission receives an Event
Report from a Long Term Care Facility Participant, the Commission will determine
whether that Event Report is complete, thorough, credible and acceptable. The definitions
for the terms complete, thorough, credible and acceptable are:
(a) A report is complete if
it contains all the information requested in the Event Report, or explains, to the
Commission’s satisfaction, why that information is not available or not necessary
to provide;
(b) A report is thorough if
the root cause analysis includes an analysis of all relevant systems issues and
shows evidence of an inquiry into all appropriate areas;
(c) A report is credible if
it shows evidence that the investigation of the Reportable Long Term Care Facility
Serious Adverse Event included participation by leadership within the organization
and was internally consistent; and
(d) A report is acceptable if
all the above standards are met and the action plans clearly describe meaningful
improvement strategies designed to minimize risk.
(2) If the Commission believes
that an Event Report received from a Long Term Care Facility Participant is incomplete
or unacceptable in some manner, it will inform the Long Term Care Facility Participant’s
contact person within 10 business days of receipt of the Event Report.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 1-2007, f. &
cert. ef. 3-9-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-020-0035
Public Health Officer Certification
(1) At least annually, the Commission
will request that the Public Health Officer certify the completeness, credibility,
and thoroughness of each Long Term Care Facility Participant's reporting to the
Commission during the applicable period.
(2) The Commission will request
that the Public Health Officer develop independent and objective standards to evaluate
the overall integrity of the Patient Safety Reporting Program. On an annual basis
the Commission will request that the Public Health Officer use those standards to
certify the Oregon Patient Safety Reporting Program.
(3) The Commission will provide
information to the Public Health Officer to assist the Public Health Officer in
completing the certification processes listed in (1) and (2) of this rule, consistent
with OAR 325-010-0050.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 1-2007, f. &
cert. ef. 3-9-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-020-0040
Patient Notification Of Reportable
Serious Adverse Events
(1) After a Reportable Serious Adverse
Event occurs, a Long Term Care Facility Participant must provide written notification
to each affected patient, or, if necessary, to the patient's personal representative.
Notification must be timely and should be consistent with the Long Term Care Facility
Participant's internal communication and disclosure policies.
(2) As provided in ORS 837(4),
notice provided under this subsection may not be construed as an admission of liability
in a civil action.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 1-2007, f. &
cert. ef. 3-9-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-020-0045
Extensions And Waivers
(1) The Commission may grant an extension
of any time requirement stipulated in these rules if the Long Term Care Facility
Participant provides justification that the delay is due to factors beyond its control
or that the delay will not adversely affect the purposes of the Commission. A Long
Term Care Facility Participant requesting a waiver must submit a written request
to the Commission prior to the deadline for the required action.
(2) The Commission may grant
a waiver of any other provision of these rules if the Long Term Care Facility Participant
provides justification that granting the waiver will not adversely affect the purposes
of the Commission.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 1-2007, f. &
cert. ef. 3-9-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-020-0050
Protection Of Patient Safety Data
(1) The Commission is subject to all
the confidentiality provisions set forth in ORS 442.820, 442.831, 442.837, and 442.846.
(2) The Commission will maintain
the confidentiality of all Patient Safety Data that identifies or could be reasonably
used to identify a Long Term Care Facility Participant or an individual who is receiving
or has received health care from the Long Term Care Facility Participant.
(3) Before it takes receipt
of any confidential Patient Safety Data, the Commission will have in place appropriate
safeguards and security measures to ensure the technical integrity and physical
safety of such data.
(4) Pursuant to ORS 442.820(4),
meetings or portions of meetings where the Oregon Patient Safety Commission Board
of Directors, or subcommittees or advisory committees consider information that
identifies a participant or patient are not subject to the Oregon Public Meetings
Law, 192.610 to 192.690.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 1-2007, f. &
cert. ef. 3-9-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-020-0055
Commission’s Use Of Patient
Safety Data
(1) The Commission will create an ad
hoc committee on best practices in patient safety. This committee will advise the
Commission on effective methods for making use of and sharing information gathered
from the Commission's review of Event Reports.
(2) At least quarterly, the
Commission will provide Long Term Care Facility Participants with aggregate patient
safety quality improvement information derived from Patient Safety Data.
(3) During the second quarter
of each year, the Commission will publish a report to the public summarizing Patient
Safety Data for the preceding calendar year. This report will use aggregate, de-identified
data from the program and will describe statewide adverse event patterns and best
practices to avoid the occurrence or minimize the effects of adverse events.
(4) The Commission will maintain
an easily accessible and well-publicized website to share patient safety information
directly with consumers.
(5) The Commission, within
its resource limitations, will provide technical assistance to Long Term Care Facility
Participants, including but not limited to recommendations and advice regarding
methodology, communication, dissemination of information, data collection, security
and confidentiality.
(6) The Commission will work
with representatives of organizations participating in the Oregon Patient Safety
Reporting Program and with other interested parties to develop recommendations for
continued improvements in the collection and utilization of Patient Safety Data.
The Commission will revise its reporting form as necessary based on feedback from
Participants.
(7) The Commission may initiate
other projects using patient safety data when consistent with its mission and in
accordance with existing confidentiality protections.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 1-2007, f. &
cert. ef. 3-9-07; PSC 2-2015, f. & cert. ef. 7-10-15

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